CyPass Micro-Stent Recalled by Alcon Research LTD. for Risk of Endothelial Cell Loss

Not sure what’s been recalled, withdrawn from the market, or had safety updates? Catch up on the US Food and Drug Administration’s (FDA’s) recalls and safety news from this past week.

CyPass Micro-Stent Recalled by Alcon Research LTD. for Risk of Endothelial Cell Loss

Due to the risk of endothelial cell loss, Alcon Research, LTD. is voluntarily recalling several models of its CyPass System.

The CyPass System is a device used for the treatment of patients with mild to moderate primary open-angle glaucoma. It is a small tube with tiny holes that is surgically implanted in the eye in conjunction with cataract surgery to reduce intraocular pressure.

Five-year post-surgery data from the COMPASS-XT long-term safety study served as the basis for the voluntary market withdrawal. Compared to the cataract surgery-only control group in the study, a clinically and statistically significant increase in corneal endothelial cell loss was noted in the CyPass Micro-Stent group.

For more information on this recall, check out the FDA’s statement.

Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Recalled by Promise Pharmacy for Small Particulate Floating in the Solution

Due to small, unidentified particulate floating in the solution, Promise Pharmacy is voluntarily recalling 1 lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3ml vials.

Prednisolone and Gatifloxacin are used as a post-surgical (cataract) ophthalmic treatment. To date, the only affected lot is Lot Number 09042018@2, Exp. 12/03/2018, which was distributed Nationwide.

Limited eye irritation, inflammation, visual impairment, and permanent ocular damage are potential adverse health consequences that could occur from use of the eye drop solution.

For more information on this recall, check out the FDA’s statement.

Raindrop Near Vision Inlay Associated with Increased Risk of Corneal Haze

Due to the risk of developing corneal haze, which can affect clear vision, the FDA is issuing a safety communication regarding the use of the Optics Medical’s Raindrop Near Vision Inlay.

The transparent, curved hydrogel disc is used to improve near vision and provide an alternative to contact lenses or eye glasses in healthy individuals.

ReVision Optics was first granted an approval for the device by the FDA in 2016. It is now owned by RVO 2.0, which is conducting business as Optics Medical.

For more information on this safety update, check out the FDA’s statement.

For FDA recalls and safety updates regarding food products, visit Contagion®’s recall list.